Headway Advanced MC172150SXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810170013751), received between Jul 12, 2017 and Aug 7, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: A HEADWAY 17 WAS USED FOR A COILING. THE WIRES WERE VERY DIFFICULT TO PUSH THROUGH THE HEADWAY AND THE HEADWAY FOLDED UP AT THE TIP WHEN THE COIL WAS PULLED BACK. PATIENT IS DOING FINE. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED LUMEN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745290 ↗
• MalfunctionJun 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SYNCHO STANDARD 014 WOULDN¿T GO THROUGH THE HUB. PROCEDURE COMPLETED AS EXPECTED. THIS COMPLAINT WAS ORIGINALLY ASSESSED AS NON-REPORTABLE. HOWEVER, BASED ON THE PRODUCT EVALUATION FINDINGS, A REPORT IS BEING CONSERVATIVELY BASED ON EXPOSED BRAID IDENTIFIED WITHIN THE MICROCATHETER LUMEN DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162574 ↗
• MalfunctionMay 12, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING THE PROCEDURE, THE OPERATOR REPORTED THAT THE CATHETER HAD A ¿WRONG/BAD LUMEN - RESISTANCE WAS FELT, THE COIL COULD NOT BE DELIVERED¿. THERE WAS NO PATIENT INJURY NOR INTERVENTION. THIS COMPLAINT WAS ORIGINALLY ASSESSED AS NON-REPORTABLE. HOWEVER, BASED ON THE PRODUCT EVALUATION FINDINGS, A VIGILANCE REPORT IS BEING CONSERVATIVELY SUBMITTED BASED ON THE INVESTIGATION FINDINGS OF EXPOSED BRAID WITHIN THE MICROCATHETER LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007399 ↗
• MalfunctionDec 10, 2024Complete Blockage; Peeled/Delaminated; Obstruction of Flow; Complete Blockage; Peeled/Delaminated; Obstruction of Flow

  IT WAS REPORTED THAT THE TECH WAS PREPPING THE HEADWAY 17 MICROCATHETER FOR A STENT PROCEDURE. WHILE FLUSHING THE MICROCATHETER, NO LIQUID WAS PASSING THROUGH TO THE DISTAL OPENING OF THE MICROCATHETER. THEY TRIED MULTIPLE SYRINGES WITH NO IMPROVEMENT. THEY FINALLY REPLACED THE MICROCATHETER WITH A FRESH ONE AND IT FLUSHED APPROPRIATELY. THE MICROCATHETER WAS NOT PLACED IN THE BODY. ALTHOUGH THE INITIAL INFORMATION RECEIVED WAS NOT DETERMINED TO BE REPORTABLE, WE ARE NOW REPORTING THE EVENT BASED ON DEVICE INVESTIGATION FINDINGS OF DELAMINATED PTFE LINER OCCLUDING THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20888938 ↗
• MalfunctionOct 9, 2024Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED: AFTER OPENING THE OUTER PACKAGING OF THE PRODUCT, IT WAS FOUND THAT THE INNER PACKAGING WAS NOT COMPLETELY SEALED. AFTER REPLACING WITH ANOTHER PRODUCT OF THE SAME SPECIFICATION, PROCEDURE WAS PERFORMED. AFTER COMPARING WITH OTHER PRODUCTS OF THE SAME SPECIFICATIONS, IT WAS FOUND THAT THE SEALING MARKS ON THE TWO ENDS OF THE PACKAGE WERE RELATIVELY SHALLOW. NO PATIENT INVOLVEMENT. PATIENT STATUS IS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413570 ↗
• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A MICROCATHETER EXPERIENCED FRICTION IN ITS LUMEN WHILE A STENT WAS BEING ADVANCED WITHIN IT. THE CATHETER AND STENT WERE REMOVED TOGETHER AND THE PHYSICIAN SELECTED A NEW STENT AND CATHETER TO COMPLETE THE CASE. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD." WHEN A PRELIMINARY TEST WAS CONDUCTED ON THE CATHETER BY THE MANUFACTURER, A STENT ADVANCED WITHIN IT EMERGED FROM THE CATHETER WITH THE CATHETER'S PTFE LINER MATERIAL ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094395 ↗
• InjuryJul 12, 2017Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING ADVANCEMENT OF A STENT THROUGH THE MICROCATHETER, THE PHYSICIAN "FELT A CRUNCH" AND THE MICROCATHETER APPEARED TO HAVE BROKEN APPROXIMATELY 50CM FROM THE HUB. THE STENT WAS REMOVED ALONG WITH THE PROXIMAL PORTION OF THE MICROCATHETER. THE DISTAL SEGMENT OF THE MICROCATHETER WAS TRAPPED AND RETRIEVED WITH A SCEPTER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708898 ↗